PK and ECG Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma

Sponsor

Soligenix (Industry)

Overall Status

Completed

CT.gov ID

NCT05380635

Collaborator

(none)

Enrollment

Location

Arm

3.3

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the blood levels of hypericin and any electrocardiogram (ECG) changes during 8 weeks of HyBryte (topical hypericin ointment) photodynamic therapy.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous T-Cell Lymphoma/Mycosis Fungoides	Drug: Hypericin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Phase 2a Study of Systemic PK and Serial ECG Determinations Following 8 Weeks of HyBryte Treatment

Actual Study Start Date :

May 9, 2022

Actual Primary Completion Date :

Aug 16, 2022

Actual Study Completion Date :

Aug 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HyBryte (0.25 % Hypericin) HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 5 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 8 weeks.	Drug: Hypericin HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment. Other Names: HyBryte SGX301

Arm

Intervention/Treatment

Experimental: HyBryte (0.25 % Hypericin)

HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 5 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 8 weeks.

Drug: Hypericin

HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.

Other Names:

HyBryte

SGX301

Outcome Measures

Primary Outcome Measures

Electrocardiograms (ECG) [10 weeks]
Assess any ECG QT interval changes during standard HyBryte photodynamic therapy.
Systemic Blood Levels [10 weeks]
Assess the systemic blood levels of hypericin during standard HyBryte photodynamic therapy.

Secondary Outcome Measures

Number of participants with treatment-related adverse events [10 weeks]
Assess the number of participants with treatment-related adverse events as assessed by severity grade (Mild, Moderate, Severe) during standard HyBryte photodynamic therapy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IB or Stage IIA
CTCL lesions covering ≥ 10% of their body surface area

Exclusion Criteria:

History of allergy or hypersensitivity to any of the components of HyBryte
Pregnancy or mothers who are breast-feeding
Males and females not willing to use effective contraception
Subjects with history of sun hypersensitivity or photosensitive dermatoses (e.g., porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, etc.)
Subjects whose condition is spontaneously improving
Subjects receiving topical steroids or other topical treatments (e.g., nitrogen mustard) on index lesions for CTCL within 2 weeks of enrollment
Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy (PUVA), narrow band ultraviolet B (UVB) light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment
Subjects who have received electron beam irradiation within 3 months of enrollment
Subjects with a history of significant systemic immunosuppression
Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment
Subjects receiving drugs known to cause photosensitization within 2 weeks of starting HyBryte therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks